M/s. Meril Endo Surgery Private Limited.
Chala, Vapi, IN
M/s. Meril Endo Surgery Private Limited. appears in FDA device records in Chala, Vapi, IN. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for M/s. Meril Endo Surgery Private Limited. between 2015 and 2025. The busiest year on record is 2024, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 3 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252644 | PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture | NEW | Substantially Equivalent | |
| K233386 | Monik™ - Disposable Endoscopic Trocar | GCJ | Substantially Equivalent | |
| K232246 | 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture | NEW | Substantially Equivalent | |
| K230981 | Meriglu Topical Skin Adhesive | MPN | Substantially Equivalent | |
| K200452 | Meril-Bonewax | MTJ | Substantially Equivalent | |
| K200320 | Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload | GDW | Substantially Equivalent | |
| K200166 | Mirus Ligating Clip, Mirus Ligating Clip Applier | FZP | Substantially Equivalent | |
| K172146 | MERISTEEL | GAQ | Substantially Equivalent | |
| K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture | GAP | Substantially Equivalent | |
| K172659 | MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture | GAM | Substantially Equivalent | |
| K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture | GAP | Substantially Equivalent | |
| K150717 | Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron | GAM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FZPClip, Implantable
- GCJLaparoscope, General & Plastic Surgery
- GDWStaple, Implantable
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
- GAPSuture, Nonabsorbable, Silk
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- NEWSuture, Surgical, Absorbable, Polydioxanone
- MPNTissue Adhesive For The Topical Approximation Of Skin
- MTJWax, Bone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain